Momenta Pharmaceuticals, Inc. (MNTA)

[flatlander_60048]

I put less weight on SNY ridiculing Amphastars capabilities since we saw much the same approach when MNTA was getting close. However, you can definately add me to the category that feels that some political force was brought to bear to gain Amphastars approval. Was the Amphastar lawsuit against FDA dismisses, retracted and the files sealed? Perhaps lawsuits are a new path to approval. I considered NVS Suit to gain Omnitrope approval more of a nudge to get the FDA to take a stand given the lack of regulatory guidance. The Amphasta claims of bias were much uglier and perhaps political pressure for a settlement due to projected litigation costs were too great for the FDA to resist. Does the FDA fund litigation from the general operating budget?

I know I tend to be too quick to claim conspiracy, but it would seem highly improbably that the FDA issues identified earlier this year would get resolved so quickly. I suspect we will never know since any agreement has been sealed, and Amphastar has now likely dropped any lawsuits against the FDA (likely part of the agreement).

FL